Vertex Pharmaceuticals creates new possibilities in medicine to cure diseases and improve people’s lives. This Director, Technical Operations – Drug Product opening is an exciting opportunity to join Vertex’s growing Technical Operations team and play a critical role in the rapid commercialization of new life-changing products in an innovative, high-science, Quality-by-Design, virtual manufacturing environment. If you are looking for an entrepreneurial, science-driven, collaborative environment where you can have a highly visible impact, then this is the perfect position for you!
The Director and his/her group partner with late-stage product development teams and contribute to regulatory filing activities in order to ensure the robustness of the drug product process in a commercial setting, and to maximize benefits derived from an advanced Quality-by-Design approach. The Director is responsible for successful process validation and commercial manufacturing, drives resolution of complex manufacturing issues, and leads global expansion activities throughout the product lifecycle in a complex, global environment. The successful candidate will champion high-impact cross-functional initiatives and maintain strong relationships with key internal and external stakeholders. This role requires proven experience in a cGMP environment, a broad understanding of the interaction between technical, regulatory, and business challenges, and strong scientific/engineering skills in order to drive continuous improvement initiatives in a global, post-approval environment.
To be successful in this role, the candidate must be an excellent collaborator with proven experience in a cGMP pharmaceutical environment, who can bring creativity and energy to their work and promote collaborative, and effective relationships with internal stakeholders and key external suppliers.
Lead drug product process validation and manufacturing activities for multiple small molecule products and processes (batch and continuous) across a global supplier network
Represent Technical Operations in leadership forums to influence late stage product development and regulatory submission strategies, minimize commercialization risks, and foster effective post-approval and lifecycle management approaches while building strong relationships with key stakeholders.
Partner with Pharmaceutical Development, Supply Chain, Quality and Regulatory to define technical transfer strategies which enable process validation and commercial manufacturing of Vertex products at new suppliers and new manufacturing sites.
Provide leadership to resolve critical issues impacting manufacturing operations in collaboration with relevant stakeholders
Design and implement functional/department goals and participate in setting goals for the overall division
Participate in shaping technical direction of department and influence support of technological innovation and creativity
Drive risk management and champion effective ongoing continuous improvement of manufacturing operations
Determine hiring plan for the group in conjunction with Senior Management. Recruit, direct, motivate, and develop staff, maximizing their individual contribution, professional growth and their ability to build and sustain a team culture of efficiency and quality
BS/MS and 12+ years or PhD with 10+ years of relevant work experience
Experience in small molecule drug product development, manufacturing operations and technical support (especially oral solid dosage forms)
Advanced knowledge of cGMP’s, associated CMC quality systems and regulatory considerations in a pharmaceutical setting
Demonstrated leadership, collaboration, and team building skills; ability to connect with all levels of the organization.
Proven ability to manage multiple high-priority projects with high degree of effectiveness.
Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
We strike at the core of serious diseases to change people’s lives. Bringing together the brightest minds, investing in science and taking smart risks, we go all in. For the lives we have changed and for those who are still waiting, we will never stop fighting until we discover cures.
We have research and development sites and commercial offices around the world, all dedicated to bringing the next transformative treatments to people with serious diseases. Our headquarters are in Boston and London.